CareDx Inc (CDNA) 2021 Q1 法說會逐字稿

Greetings and welcome to the CareDx, Inc. First Quarter 2021 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Greg Chodaczek from Gilmartin Group. Please go ahead.

Thank you. Good afternoon and thank you for joining us today. Earlier today, CareDx released financial results for the quarter ended March 31, 2021. The release is currently available on the company's website at www.caredx.com.

Reg Seeto, Chief Executive Officer; and Ankur Dhingra, Chief Financial Officer, will host this afternoon's call.

Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical facts should be deemed to be forward-looking statements. All forward-looking statements, including, without limitation, our examination of historical operating trends, expectations regarding coverage decisions, pricing and enrollment matters, and our future financial expectations and results are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and descriptions of these risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission.

The information provided in this conference call speaks only to the live broadcast, May 5, 2021. CareDx disclaims any intention or obligation, except as required by law, to update or revise any information, financial projections or other forward-looking statements whether because of new information, future events, or otherwise. This call will also include a discussion of certain financial measures that are not calculated in accordance with the generally accepted accounting principles. Reconciliation to the most directly comparable GAAP financial measure may be found in today's earnings release filed with the SEC.

I will now turn the call over to Reg.

Thanks, Greg. Good afternoon, everyone, and thank you for joining us. Welcome to CareDx's First Quarter 2021 Earnings Conference call.

We had a very strong start to the year with a record first quarter result. Our vision of being leader in the transplant ecosystem continues to resonate as we remained focused on the transplant patient. As the largest transplant focused company in the U.S., we're proud to be the leader in innovation by bringing the first and best-in-class transplant-specific technologies through AlloMap gene-expression profiling and AlloSure donor-derived cell-free DNA. Notably, we are again first in driving new transplant innovation.

We recently introduced the first and only recognized multimodality approach with heart care, which laid the foundation for kidney care in future years in other organs. I am proud [to linear] company continues to invest to bring innovation, especially sort of transplant, which is often overlooked. As the CEO of CareDx, I am continually being told or should I say reminded that we are the transplant company. On behalf of CareDx, I'm proud to accept that title and association.

For our record first quarter, total revenue was $67.4 million, increasing 76% compared to year ago quarter. The driver of the quarter's growth was our testing services revenue which increased 89% to $59.3 million and we also saw the products revenue increase 23% to $5.8 million.

Digital and other revenues added $2.3 million to the top line. GAAP net loss for the first quarter was $0.07 million and adjusted EBITDA was positive $7.7 million. We remain focused on driving top line growth through increased adoption of our offering and continuing to invest in a rich pipeline across the transplant journey.

During the first quarter, we made significant progress along the following 3 fronts. One, advancing our testing services model; 2, expanding our direct to patient strategy; and 3, building our future pipeline through investing in specific scientific data and innovation.

I'll tackle the first one, advancing our testing services model. In the first quarter, CareDx provided approximately 33,200 AlloSure and AlloMap test results to transplant patients growing approximately 121% from the first quarter of 2020. Of these, approximately 5,000 from our tests were part of heart care. Our focus has always been on our direct to center strategy with more than 150 kidney and more than 100 heart centers using our offerings during the first quarter. We feel very good about our strategic focus on building a moat around the center.

As of the end of March, over 60 kidney transplant centers in the United States have now adopted AlloSure named testing protocol into their standard of care. We've also continued to expand our moat in centers. With the prior acquisition of OTTR, we've seen the benefit of offering transplant-specific software to improve U.S.-based transplant centers OTTR worked for. In January, we announced the acquisition of TransChart LLC, an electronic health record software provider supporting U.S. transplant center needs.

This acquisition added over 20 centers using TransChart. We believe offering an efficient end-to-end solution for transplant centers will lead to further adoption of our high-value health care solutions. Our strategy, this strategy, the focus on the transplant centers to build adoption in protocols has been very successful.

In addition, we recently started expansion into community nephrology setting. During this quarter, and now with the full team for the first time, we had more than 100 community practices start using AlloSure in the last quarter, with several ready starting protocols. Our community dedicated team is doing a great job. Although early, we've been very pleased with the ability to continue our patient care from the center of the community with our patient care managers and through our AlloCare app.

This focus on innovation was evidenced first hand as the recently announced universal solid organ transplant LCD by Palmetto MolDX now provides a pathway for our future pipeline and multimodality surveillance approach to be introduced. We are proud to be leading the way, especially with multicenter and prospective data sets to generate the clinical ability and utility for patients, physicians, and payors. It takes a leader to invoke change and we are grateful as a leader to all the patients, physicians, coordinators, caregivers, that work with us as leaders in leading change and bringing much needed innovation to the transplant journey.

We talked about AlloSure lung update in Q3 at our last earnings call. But the recent universal LCD now includes the path for lung. The universal LCD can accelerate adoption for lung surveillance and our pipeline. We've previously submitted our technical assessment of AlloSure lung and we look forward now to review of this submission within Q2, 2021.

This model also provides the path for future comprehensive multimodality pipeline development and which we are very excited about because this will provide how we developed kidney care and lung during other flawed organs in bridging -- in bringing this incremental utility as high value to physicians and centers. Our studies have been designed and developed this way. We look forward to updates on kidney care during the course of the year.

On the second topic on expanding direct-to-patient strategy. During our last earnings call, I mentioned that 2021 would be a direct-to-patient theme, which makes CareDx an open-ended storing physician medicine. During the first quarter, we expanded into the pre-transplant patient journey and acquired TX Services, the provider of TX Connect.

TX Connect is a cloud-based service that allows nephrologists and dialysis centers to electronically submit referrals to transplant programs, closely follow these patients and assist these patients through the transplant wait list process and ultimately the goal being transplantation.

TX Connect now manages more than more than 20,000 referred dialysis patients and is fully integrated within TransChart. More than 30 transplant centers and over 500 dialysis centers are now involved with this offering. This offering will allow us to better serve transplant centers as dialysis centers refer end-stage kidney patient disease to these patients to be assessed for transplant. Adding TX Connect to our robust digital platform will help us provide more integrated care at every critical step of that transplant patient journey.

On the post-transplant patient journey, our decision for the rapid implementation of RemoTraC last year as COVID was beginning to spread through U.S. has given transplant patients the option of having their blood drawn outside the confines of a hospital or a transplant center and at the safety of their homes. Despite the number of new COVID infections decrease in U.S., transplant patients are still at higher risk of getting severely sick from COVID and we believe RemoTraC is the appropriate solution to limit a transplant patient from potential exposure.

And our patient care managers are doing a great job in supporting patients and transplant centers with valuable support. With the continued impact of COVID-19, we saw the use of RemoTraC and mobile phlebotomy about 40% for the quarter. As of March 31, 2021 we had over 7,000 patients on RemoTraC.

Now on the third topic. On building a future pipeline through again investing in scientific data and innovation. This is the hallmark that sets us apart. Throughout 2021, we will continue to build upon our interest-leading clinical data and plan to present at multiple industry events as we continue to drive innovation and be the leader in high value health care solutions to transplant patients caregiver.

Our clinical team under leadership of Dr. Sham Dholakia has been exceptional. They've been very busy over the last few months as new data sets were presented and showcased at multiple industry events. We continue to generate the highest number of abstracts and presentations for a transplant company and this centers around our focus innovation, which is what really continues to set us apart from opportunistic entrants.

The testing services. We presented new transplant data in January at the ASTS Conference, the American Society of Transplant Surgeons. During this conference, we sponsored 2 symposia with key clinical leaders discussing real world experiences, including AlloSure to optimize care for their transplant patients with initial data from the ADMIRAL study and the rollout of the MAPLE study for AlloSure Liver.

For this year's ATC Conference, we will have over really 30 accepted abstracts and so continue to lead with science innovation. Combining what we presented last week with over 20 abstracts at the ISHLT Conference and with the 30 from ATC that will be coming up, that's more than 50 abstracts at 2 major conferences from CareDx, more than 50 abstracts from one company. Again, we're very proud of this.

Back to ADMIRAL. ADMIRAL is a multicenter, 2-year follow up study using patients who have had AlloSure as part of their standard-of-care, while care 1000, a study setting, is an early snapshot at the 1-year mark for the first 1,000 patients in the KOAR study. We're really excited and proud to be bringing the first long-term and only multicenter prospective datasets from the transplant community and the clinical utility they show as we submit AlloSure into the standard-of-care of transplant patients.

In addition, during last month's National Kidney Foundation's spring meetings, we had 2 well-attended programs, featuring the latest kidney transplant surveillance data. The pipeline for new offerings continues to strengthen with the addition of our development program for AlloID. Early in 2021, we announced a partnership with IDbyDNA to develop management of infectious disease testing specific to transplant patients.

AlloID will identify more than 100 pathogens and drug resistance in viruses and bacteria. Our customers have indicated very strong interest in adding the value of this testing for managing the health of immunocompromised immunosuppressed patients.

In the products business, we saw continued transition to our AlloSeq franchise, represented by hybrid capture technology. Over half the product revenue now comes from this NGS technology. During the first quarter, we also acquired BFS Molecular, a software company focused on next generation sequencing-based testing solutions. The addition of BFS Molecular software and algorithm development will further enhance our offering of world-class bioinformatics and transplant surveillance software. And to new areas, such as AlloCell, we showcased the CareDx cellular transplant therapies portfolio at the recent TCT Conference, the Transplantation and Cellular Therapy Conference in February.

Included in those presentations was a post that we presented with our partner Atara Biotherapeutics on potential use of AlloCell, the standardized pharmacokinetic assessment, in a clinical trial. While this is still early, we are very excited about the value AlloCell can bring to Atara's clinical trial development of allogeneic cell therapy.

Our offerings are making significant difference in the transplant patient journey setting. We are building capabilities required to scale this business and realize the tremendous potential in front of us. During this quarter, we enhanced our leadership team with key appointments and also further strengthened our financial position.

Starting with the former, we announced new senior leadership appointments to create meaningful impact across these key growth areas to build for that future, and to enhance that patient journey. Including these announcements was hiring of Ankur Dhingra, our new Chief Financial Officer. Ankur brings extensive experience to CareDx with over 25 years of finance and accounting experience achieved in the Life Sciences sector. We're really excited to have Ankur join the CareDx family and I hope you will have the opportunity to meet him during the course of this year.

In the first quarter, we also significantly strengthened our cash position. We closed the quarter with $374.3 million in cash following a very successful executed public offering in January. Our balance sheet allows us to continue to drive revenue growth and take full advantage of opportunities available to us. Our capital deployments strategy remains focused on making meaningful impact in that transplant patient journey. As we look to the rest of 2021, there's lots to be excited about.

With that, I will turn over the call to Ankur to discuss our financials and our updated 2021 revenue guidance.

Thank you, Reg. Hello, everyone. I'm very excited about being a part of such a dynamic organization. Over the past several years, CareDx has transformed itself into a premier diagnostics company and the leader in health care solutions for transplant patients and caregivers. In my first few weeks here at CareDx, my conviction has only grown stronger that CareDx is uniquely positioned to realize this tremendous opportunity.

Turning to the income statement. Our first quarter of 2021 testing services revenue increased 89% year-over-year to $59.3 million. The first quarter testing services revenue growth was driven by AlloSure Kidney and AlloMap Heart patient results and an excellent start to AlloSure Heart. Our first quarter product revenue increased 23% year-over-year to $5.8 million, and our digital and other revenue was $2.3 million.

Moving to gross margins. For the first quarter, the gross margin was 68% compared to a gross margin of 68% in the same period of 2020. The non-GAAP gross margins for the quarter was 70% compared to 71% in the prior year's quarter. As you may recall, last year in Q2, we successfully built our RemoTraC service, which has been and continues to remain a big enabler of transplant patients to limit exposure to COVID.

For the first quarter of 2021, net loss was $0.7 million compared to a net loss of $5.8 million in the same period last year. Our net loss per share was $0.01 for the quarter compared to a net loss per share of $0.14 in the first quarter last year.

On non-GAAP net income, our first quarter net income was $7.2 million compared to a non-GAAP net income of $0.2 million in the same period. The basic and diluted non-GAAP net income per share for the first quarter of 2021 was $0.14 compared to $0.0 in the same period of 2020. As a reminder, we define adjusted EBITDA as non-GAAP net income before interest, income tax, depreciation, amortization and other expense.

For the first quarter of 2021, we recorded positive adjusted EBITDA of $7.7 million compared to an adjusted EBITDA gain of $0.2 million last year in the same quarter. Our focus remains on driving top line growth and continuing to expand our reach in the transplant ecosystem through our innovative products, services and a rich pipeline and also efficiently scaling our business.

Moving to the balance sheet. Cash, cash equivalents and marketable securities at March 31, 2021 was $374 million. As Reg mentioned, we strengthened our cash position in the quarter as we successfully completed a public offering of approximately 2.2 million shares of common stock, raising roughly $189 million in net proceeds.

In January, we repaid the CMS advance payment of approximately $20.5 million in full. Adjusting for this CMS repayment and timing of certain annual outflows, our operating cash flow was neutral for the quarter.

Turning to guidance. We are updating our 2021 revenue expectations to reflect our strong first quarter results and continued strong demand for our solutions. As of today, we anticipate $270 million to $280 million in revenue for the year. This represents an increase of $15 million at the midpoint versus our earlier guidance. Our new guidance balances the uncertainties around the ongoing pandemic and the continued market penetration of our products and services.

We are very excited about the opportunities in front of us and the team is off to an excellent start to 2021.

With that, I will open the call for questions.

(Operator Instructions) The first question is from Brandon Couillard from Jefferies.

Reg and Ankur, if I just annualize the first quarter revenue, that would get me to the low end of the new range for the year, which is $270 million, which would seem pretty conservative if you sort of look out over the balance of the year. What are some of the puts and takes that would get you to the high end or above that new revenue outlook for the year? And Ankur, any update in terms of some of the OpEx items for '21?

Yes Brandon, we're really excited about the quarter we just had. It was a great Q1, just getting cooperation of AlloSure Heart for the first quarter. And we've got 3 unique business lines which continue to grow at different rates. Really excited about the testing services, which is growing well above the 50% range, the products business which is in the 10% to 20% range and also we have the -- also in single digits, the digital business. So as we look at that, I'm going to let Ankur comment a bit about the actual guidance range that we have set.

Yes, sure. So Brandon, as we were looking at the expectations for the year and considering that we're off to an excellent start for the quarter, as Reg was saying, we saw great execution by the team, an excellent first quarter both on AlloSure Heart, the HeartCareas well as the penetration in the nephrology setting. So very, very pleased with the momentum there. And then as we started looking at the entire year expectation, kind of took our first quarter performance and then grazed the remainder of the year.

At the low end, you're right, we've anticipated a continued strong performance similar to what we had in Q1, represents that lower end. And then high end, that represents our ability to continue to penetrate in that market, especially around the nephrology setting. Our aim is to keep working that. And as we continue to make further progress on the nephrology market, we'll keep looking at it through the year.

Got you. Then in terms of AlloSure Heart, the 5,900 tests that you ran in the first quarter, what's the capture rate in terms of number of heart patients that are getting an AlloSure Heart test as well? And has the mix changed at all in terms of the Medicare versus commercial payers? And have you begun a dialogue with some of those commercial payers yet, or is that less of a near term priority?

Yes, we were. Again, AlloSure Heart, we had the first full 3 months. And for us, it was really exciting to have that fully rolled out, particularly if you look at the different attachment rates increased during this quarter. I'll hand over to Ankur to make a full comment.

Yes, from a heart care perspective, we saw slightly north of 80% attach rate for our new product there on AlloSure Heart. And we're still -- there is a Medicare mix in it and there is a fairly high sizable mix of commercial participation there as well. We expect the commercial side to slowly convert to revenue over a period of time.

(Operator Instructions) The next question is from Andrew Cooper from Raymond James.

I guess really first, I want to focus in on gross margins for a second here on the testing services side. It was down sequentially, but you had more tests and importantly, more AlloSure Heart than I would have thought would really be driving that number higher. Is there anything to think about there, whether it's some of the data generation costs and sort of R&D costs that are captured in gross margin? Or how should we be thinking about that metric? Because I would have expect all else being equal that maybe it was trending a little bit higher than sort of what we see in the last 2 quarters.

Yes, so maybe I'll just clarify first and I'll hand it over to Ankur. As a reminder, with AlloSure Heart, we had -- prior to getting commercial approval, we had 60% of these testing done on a research basis and now it's up to, as Ankur mentioned, above 80%. So we've actually -- the test previously there on the research side were not included in terms of the numbers we provided. So I think now what you seeing with that 5,900 is including those at baseline, for example 60% over there. So I'm going to hand over to Ankur to answer that.

Yes, so on the margin side, we don't see any structural issues there, is one. We continue to invest further in RemoTraC with our direct to patient part of the journey. And that part reflects primarily in the testing services side of things. So moving forward, we do expect as we build out RemoTraC there will be some more investments through the year. But overall, from our ability to drive margins purely from our testing services perspective, remains intact.

Okay. That's helpful. And then maybe just clarify, I know you said Reg 2Q for -- and on the tech assessment on lung, but can you give us a little bit more flavor on what you think payment could look like when it could start and sort of what the process from there is? And then maybe just lay out how you think about sort of the next phase, what's after lung, if that was easy changes or the way you approached CMS and approached doing MolDx timing on any of the other organs or anything to that effect?

Yes, I think again we afford the universal LCD, we believe is the market leader. It allows us now to bring other solid organs in the frame. Lung is obviously the next one that would be -- we'd be bringing into the transplant community, as mentioned in the prepared statements. This discussion will happen during the course of this quarter and we're looking forward to those discussions. It sort of brings forward some of the initial guidance we had given in the prior quarter, which was we expect those discussions having in Q3.

So we're really excited by this opportunity, this universal city, because it creates this pathway for a faster coverage for different solid organs. And I think you know that we also have liver as part of the MAPLE study that we have with AlloSure Liver. And obviously, you should consider that all other organs, it's all fair game in that sense that we'll be looking at as well if we haven't already started.

So I think you all know us as leaders in the space and we'll continue to bring AlloSure across all those solid organs. So that's part of the -- that approach won't change and once we do then we'll bring the multimodality pathway.

Okay. And just to be clear, nothing from lung included in the guide, correct?

Correct.

Looking at cost up there -- and I'll follow-up offline. I appreciate it.

Thank you.

The next question is from Alex Nowak of Craig-Hallum Capital Group.

I just wanted to follow-up to Andrew's last point there, the LCD change. Just any comment on how the announcement changes the time lines for kidney care here? Because this has always been a -- AlloMap Kidney has always been the kind of idea out there, but it's always been a few years out. So what's that you are going to do on a AlloMap Kidney, how could this pull forward? Any sort of announcements of reimbursement there and just what to expect over the next couple of years?

Yes, Alex, it's a great question because I think we were excited when we saw the universal LCD because now it lays out the pathway of multimodality, but also recognizes the value that multimodality can bring by demonstrating this incremental clinical utility, and it's the first and only company that's done that so far in heart care. We were really excited to see that included as part of the universal LCD.

And so what that means is that we've actually -- that's what we're doing with kidney care. Kidney care actually looks at the addition of multiple technologies to increase that clinical utility and now this universal LCD provides that pathway. So as we learn more about it, I think this brings forward the potential for how we would view our multimodality offerings given that, A, the precedence will set, but B, also the guidance there provided as part of that. So I think that's probably -- your assumption I think is correct.

And the studies there are still supposed to read out end of this year, early next year on AlloMap Kidney?

Yes, the study will actually complete OKRA by the -- enrollment by the end of the year, but there are datasets we can obviously out and obviously one of the key things is developing a publication.

Yes, okay, that makes sense. And maybe to previous some of the clinical utility data on KOAR that you're going to present at the American Transplant Congress, just any particular endpoints we should be watching for as the EGFR improvement or graft survival?

Yes, that tail endpoints that we'll describe and I think thinking of what we've seen also, the ADMIRAL study was not a bad way as a proxy of looking at it. So I think correlations with EGFR is the right way to think about it, looking at the formation of de novo DSA is not a bad way to think about it. So I think also looking at even what are the learnings from different types of [Bob's] interpretations subclinical rejections.

So I think as you go through the different learnings, which were highlighted through ADMIRAL, which was also a long term multicenter study, and I think one could expect to get some parallels from that.

Okay. That's great. And just one more question if I could, just on the vaccine data and transplant patients. We've seen the results have been suboptimal. How do you think that influences the use of AlloSure now and throughout the standard of care going forward? Because last year and even Q1 here, it seems like there was a real pull forward non-invasive options. Do you think the vaccine data is going to make that dynamic stick even more going forward?

Yes, no, absolutely. I mean I think we have -- what we have learned in -- I've been in the field for the last 4 weeks talking to 2 different doctors and that's being one of the key data points that's come up with how patients aren't fully -- aren't vaccinated and there was concern with these patients in how we can continue to monitor and even with the vaccines that are available.so yes, no I'd say I think your -- again, Alex, your interpretation is correct.

The next question is from Steven Mah from Piper Sandler.

Congrats on a great quarter.

Thanks.

So, yes, my first question, so the patient engagement initiative, the direct to patient and community nephrologists with Transplant Connect, AlloCare and others, patient care managers, so these tend to be really working to drive adherence and new patient adoption. Could you give us a sense of which one of those levers is having the most impact on your volume growth?

Steven, it's Reg. No, I think all the different areas you mentioned, particularly outpatient care managers, the use of the AlloCare platform, they're all contributing to managing here. And I mean I think as a reminder, when outpatient care managers actually do the scheduling and the calling, the adherence rate is double that of when the center does it. So there's actually this premium service that's offered and also this relationship that's built in. It's all about building this overall relationship with making that stickiness be there as well and that's where that AlloCare platform comes in. So I think all things are contributing, but I think it will start with the patient care manager.

Okay. Got it. All right. That does that makes sense. And then maybe pivoting over to AlloCell, can you provide any updates on your AlloCell partnerships? I know you're limited to what you can say with your partners, but maybe without naming names, could we get a sense on the number partners you have? And how should we be thinking about the timing of new partnerships and also clinical milestones and how you're going to update investors on progress in AlloCell?

AlloCell Therapy and AlloCell business is one which is -- had a lot of, as we mentioned, excitement interest as we've engaged with partners. I think we continue to see strong interest and participation on partners. I think there were 2 variables we mentioned. One is when we can probably disclose those. But the second also is it would also be dependent on their progression through different clinical stage milestones.

So, for example, if there was a partner whose study did not progress, for example, right, and so then that limited the very progress he was making there. So as we go through a new field which we think is absolutely exciting, this progression is absolutely important for us that these partners continue to evolve through the clinic. But overall I think we are still holding a strong position. Being the first in this space, we see strong interest and I think it's going to be a partnership in learning working with these different companies that are creating that breakthrough.

Okay. Great. And final one for Ankur, so are we were talking about RemoTraC a little bit. You guys are currently at 40%. What do you think the steady state level of RemoTraC will be going forward? And how do you think about the long-term impact on gross margins and your long-term goal of getting to 75% gross margins given the additional cost of the remote phlebotomy?

Yes, I think we are at the levels that we are at now in that 40%, give or take a few points range. And our expectation is that that's a good run rate. We don't expect substantial changes here in the near term. And that's our view from the long-term perspective as well, is to say the size of the investment that we've made substantially represents a good structure for us for the medium term here and enables us continuing improvement in the gross margins, especially from a path to 75% perspective. Yes, I think we've made majority of the investment there.

Okay. Great. And congrats again.

Thanks.

This concludes the question-and-answer session. I would like to turn the call back over to Reg Seeto for closing remarks.

Again, on behalf of CareDx I want to say how excited we are to have such a great strong start to 2021. Our mission is clear on how we bring innovation and continue to make a difference in the lives of transplant patients in terms of increasing their long-term outcomes, survival of their organs. And so with that, I want to thank everyone for dialing and staying, listening to how we progressed as a company, and we'll catch you during the subsequent fall calls. Thank you.

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.